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Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk (CHP)

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ClinicalTrials.gov Identifier: NCT03386110
Recruitment Status : Not yet recruiting
First Posted : December 29, 2017
Last Update Posted : January 4, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Tyrel Starks, Hunter College of City University of New York

Brief Summary:
This project tests the feasibility, acceptability, and preliminary efficacy of the Couples Health Project (CHP). CHP is a brief (3-session) couples-based Motivational Interviewing intervention which addresses drug use and sexual HIV transmission risk among partnered HIV negative YMSM (ages 18-29). The proposed project includes a randomized controlled trial (RCT) involving 50 couples who are randomized to complete either the CHP intervention or an attention-matched education control condition.

Condition or disease Intervention/treatment Phase
Risk Behavior Drug Use Sex, Anal Behavioral: Couples Health Project (CHP) Behavioral: Education Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Couples Health Project (CHP)
The CHP intervention is a three session intervention that occurs once a week for three weeks. The CHP intervention will be delivered by MI-trained mental health counselors. The CHP intervention is comprised of 3 sessions. 25 couples will be allocated to this arm.
Behavioral: Couples Health Project (CHP)
The CHP intervention focuses on addresses drug use and HIV transmission risk by enhancing dyadic communication skills and motivation to work towards shared health goals. The last session of the CHP intervention consists of a Couples HIV Testing and Counseling (CHTC) session.
Active Comparator: Education
The Education intervention is a attention-matched control three-session intervention that occurs once a week for three weeks. The education intervention will be delivered by trained health educators. The education intervention is comprised of 3 sessions. 25 couples will be allocated to this arm.
Behavioral: Education
The Education intervention consists of a 3-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format with a male couple. Additionally, the last session of the education intervention consists of a Couples HIV Testing and Counseling (CHTC) session.



Primary Outcome Measures :
  1. Number of drug use instances [ Time Frame: 6 months ]
    Self-report

  2. Positive drug assays [ Time Frame: 6 months ]
    Drug test via fingernail assay

  3. Number of HIV transmission risk events [ Time Frame: 6 months ]
    Self-report of condomless anal sex (CAS)

  4. Positive sexually transmitted infection (STI) test [ Time Frame: 6 months ]
    STI test via urinalysis and rectal swab


Secondary Outcome Measures :
  1. Communication skills [ Time Frame: 6 months ]
    Self-report



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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligibility is based on self-identification of a male birth gender and current self-identification of a male gender identity of both parts of the couple.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Both members must be 18 to 29 years of age
  • Both members born male and currently identify as male
  • At least one member of the couple reports an HIV-negative serostatus
  • Couple has been together for at least 3 months
  • The use of at least one of the following substances in the past 30 days (only one partner) Marijuana, cocaine/crack, amphetamines, ecstasy, GHB, ketamine, nitrates, Rx drug misuse
  • At least one member of the couple, in the past 30 days, had condomless anal sex (CAS) with a casual partner and/or CAS with a non-monogamous or serodiscordant main partner.
  • Both members must be able to communicate English
  • Both members must be reside in the NYC metro area

Exclusion Criteria:

  • Either member of the couple reports IPV, which is defined as serious physical or sexual violence that occurs outside the context of consensual bondage or sado-masochistic sexual play, which results in concerns of safety.
  • Inconsistencies between information provided in the eligibility screener and the in-person meeting or any issues that might hinder participation. The couple may also be deemed ineligible if participant responses are sufficiently inconsistent to call into question the validity of their individual responses
  • The couple reports a sero-concordant HIV-positive serostatus
  • Unstable, serious psychiatric symptoms (assessed at Baseline)
  • Currently suicidal/homicidal
  • Evidence of gross cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386110


Contacts
Contact: Tyrel J Starks, PhD 212-206-7919 ext 934 tstarks@hunter.cuny.edu
Contact: Jeffrey T Parsons, PhD 212-206-7919 ext 900 jeffrey.parsons@hunter.cuny.edu

Sponsors and Collaborators
Hunter College of City University of New York
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Tyrel J Starks, PhD Hunter College of City University of New York

Publications:
Responsible Party: Tyrel Starks, Associate Professor of Psychology, Hunter College of City University of New York
ClinicalTrials.gov Identifier: NCT03386110     History of Changes
Other Study ID Numbers: R34DA043422 ( U.S. NIH Grant/Contract )
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: A databank may be used to share data consistent with the NIH resource sharing agreement. The requester will contact the PI of the study and the PI will contact the CUNY Office for Research Compliance per university guidelines for data sharing.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tyrel Starks, Hunter College of City University of New York:
Couples
MSM
HIV
Drug Use